BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1101883 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04792
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NO STIMULATION AND LACK OF EFFECT. THE IPG WAS REPLACED. NO SURGICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention EXPLANTED| EXTENSION MODEL 3095 LOT # NAH039130V IMPLANTED| EXPLANTED| LEAD MODEL 3889 LOT # V122477 IMPLANTED